Brain Research to Ameliorate Impaired Neurodevelopment - Home-based Intervention Trial (BRAIN-HIT)

Jan L. Wallander, Elizabeth McClure, Fred Biasini, Shivaprasad S. Goudar, Omrana Pasha, Elwyn Chomba, Darlene Shearer, Linda Wright, Vanessa Thorsten, Hrishikesh Chakraborty, Sangappa M. Dhaded, Niranjana S. Mahantshetti, Roopa M. Bellad, Zahid Abbasi, Waldemar Carlo

Research output: Contribution to journalArticle

Abstract

Background: This randomized controlled trial aims to evaluate the effects of an early developmental intervention program on the development of young children in low- and low-middle-income countries who are at risk for neurodevelopmental disability because of birth asphyxia. A group of children without perinatal complications are evaluated in the same protocol to compare the effects of early developmental intervention in healthy infants in the same communities. Birth asphyxia is the leading specific cause of neonatal mortality in low- and low-middle-income countries and is also the main cause of neonatal and long-term morbidity including mental retardation, cerebral palsy, and other neurodevelopmental disorders. Mortality and morbidity from birth asphyxia disproportionately affect more infants in low- and low-middle-income countries, particularly those from the lowest socioeconomic groups. There is evidence that relatively inexpensive programs of early developmental intervention, delivered during home visit by parent trainers, are capable of improving neurodevelopment in infants following brain insult due to birth asphyxia.Methods/Design: This trial is a block-randomized controlled trial that has enrolled 174 children with birth asphyxia and 257 without perinatal complications, comparing early developmental intervention plus health and safety counseling to the control intervention receiving health and safety counseling only, in sites in India, Pakistan, and Zambia. The interventions are delivered in home visits every two weeks by parent trainers from 2 weeks after birth until age 36 months. The primary outcome of the trial is cognitive development, and secondary outcomes include social-emotional and motor development. Child, parent, and family characteristics and number of home visits completed are evaluated as moderating factors.Discussion: The trial is supervised by a trial steering committee, and an independent data monitoring committee monitors the trial. Findings from this trial have the potential to inform about strategies for reducing neurodevelopmental disabilities in at-risk young children in low and middle income countries.Trial Registration: Clinicaltrials.gov NCT00639184.

Original languageEnglish (US)
Article number27
JournalBMC Pediatrics
Volume10
DOIs
StatePublished - Apr 30 2010
Externally publishedYes

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Asphyxia
Parturition
House Calls
Brain
Research
Counseling
Randomized Controlled Trials
Clinical Trials Data Monitoring Committees
Morbidity
Zambia
Safety
Pakistan
Health
Infant Mortality
Cerebral Palsy
Child Development
Intellectual Disability
India
Mortality

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Wallander, J. L., McClure, E., Biasini, F., Goudar, S. S., Pasha, O., Chomba, E., ... Carlo, W. (2010). Brain Research to Ameliorate Impaired Neurodevelopment - Home-based Intervention Trial (BRAIN-HIT). BMC Pediatrics, 10, [27]. https://doi.org/10.1186/1471-2431-10-27

Brain Research to Ameliorate Impaired Neurodevelopment - Home-based Intervention Trial (BRAIN-HIT). / Wallander, Jan L.; McClure, Elizabeth; Biasini, Fred; Goudar, Shivaprasad S.; Pasha, Omrana; Chomba, Elwyn; Shearer, Darlene; Wright, Linda; Thorsten, Vanessa; Chakraborty, Hrishikesh; Dhaded, Sangappa M.; Mahantshetti, Niranjana S.; Bellad, Roopa M.; Abbasi, Zahid; Carlo, Waldemar.

In: BMC Pediatrics, Vol. 10, 27, 30.04.2010.

Research output: Contribution to journalArticle

Wallander, JL, McClure, E, Biasini, F, Goudar, SS, Pasha, O, Chomba, E, Shearer, D, Wright, L, Thorsten, V, Chakraborty, H, Dhaded, SM, Mahantshetti, NS, Bellad, RM, Abbasi, Z & Carlo, W 2010, 'Brain Research to Ameliorate Impaired Neurodevelopment - Home-based Intervention Trial (BRAIN-HIT)', BMC Pediatrics, vol. 10, 27. https://doi.org/10.1186/1471-2431-10-27
Wallander, Jan L. ; McClure, Elizabeth ; Biasini, Fred ; Goudar, Shivaprasad S. ; Pasha, Omrana ; Chomba, Elwyn ; Shearer, Darlene ; Wright, Linda ; Thorsten, Vanessa ; Chakraborty, Hrishikesh ; Dhaded, Sangappa M. ; Mahantshetti, Niranjana S. ; Bellad, Roopa M. ; Abbasi, Zahid ; Carlo, Waldemar. / Brain Research to Ameliorate Impaired Neurodevelopment - Home-based Intervention Trial (BRAIN-HIT). In: BMC Pediatrics. 2010 ; Vol. 10.
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AU - Goudar, Shivaprasad S.

AU - Pasha, Omrana

AU - Chomba, Elwyn

AU - Shearer, Darlene

AU - Wright, Linda

AU - Thorsten, Vanessa

AU - Chakraborty, Hrishikesh

AU - Dhaded, Sangappa M.

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